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An Open-Label, Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose- Agarose Macrobeads in the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

An Open-Label, Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose- Agarose Macrobeads in the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel


Inclusion Criteria:



- Cancer of prostate

- Evidence of metastasis

- Failed available therapies

- Resolution of any toxic effects of previous therapies

- Performance status (ECOG PS) 0-2

- Adequate hematologic, coagulation (INR 2-3max), hepatic and renal function

- Life expectancy of 12 months

- Agrees to contraceptive use while on study if sexually active

- Sign informed consent document

Exclusion Criteria:

- Any condition presenting an unacceptably high anesthetic or surgical risk

- HIV positive

- Cognitive impairment such as to preclude informed consent

- Other surgical treatment, chemotherapy and radiation within four weeks of baseline

- Inadequate hematologic, coagulation (INR >3), hepatic, renal function

- Hepatic blood flow abnormalities and/or large-volume ascites

- Concurrent cancer of any other type except skin cancer (excluding melanoma)

- History of allergic reactions to mouse antigens

- Active infection, congestive heart failure, unstable angina, serious cardiac
arrhythmias, psychiatric illness, difficult social situations not permitting reliable
participation, active bleeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor volume

Outcome Time Frame:

16 months

Safety Issue:

Yes

Principal Investigator

Barry H Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Rogosin Institute

Authority:

United States: Food and Drug Administration

Study ID:

1003010955

NCT ID:

NCT01174368

Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Renal Cell
  • Prostatic Neoplasms

Name

Location

The Rogosin InstituteNew York, New York  10021